November 29, 2017 Article in Bioprocess International Vol 15, Issue 10, November 2017

"Antibody–Drug Conjugates: Fast-Track Development from Gene to Product"

Allan Watkinson*, Anja Trapp**, Jadranka Koehn**, Colin McKee***, and William Stimpson*
* Envigo, ** Rentschler Biopharma SE, ***ADC Biotechnology Ltd.

In the fight against cancer, antibody-drug conjugates (ADCs) represent an increasingly important therapeutic approach. These biopharmaceuticals are designed to maximize the therapeutic index of cytotoxic small-molecule drugs through their selective delivery to tumor cells while leaving normal, healthy cells untouched.

Product development represents a major obstacle to delivering these new therapies to patients. The industry is striving to streamline operations, reduce timelines, and minimize risk. The authors have described a fast-track "gene to ADC product" approach using a series of platform technologies to provide a lead candidate rapidly for development.

This approach includes the use of Rentschler Biopharma's TurboCell™ platform for rapid stable cell line development for the manufacturing of the antibody components based on site directed integration of the gene of interest. From selection of the gene, an antibody can be manufactured in laboratory-scale quantities within eight weeks.

Similarly, the chemistry for a range of linker-toxin conjugations can be optimized, and developmental material can be produced within four weeks. Finally, a developability risk assessment can provide both a lead candidate and related "prior knowledge" in line with the QbD paradigm within another eight weeks. The overall outcome represents time, cost, and resource savings in the development of an ADC product.

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